Clinical trials

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Phases of Clinical Trials

Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.

• Phase I trials aim to find the best dose of a new drug with the least side effects. The drug is tested in a small group of 15 to 30 people.
• Phase II trials give the drug to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III trials give the drug to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV trials are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Types of Clinical Trials

There are several types of clinical trials, including:

• Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of life trials (or supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Importance of Clinical Trials

Clinical trials are crucial in determining the effectiveness of treatments and interventions in a real-world population. Without clinical trials, there is no systematic way to determine whether new treatments are safe, effective, and better than current treatments. Clinical trials also help to identify side effects and possible adverse reactions to new treatments.

Participation in Clinical Trials

Participants in clinical trials can include a wide range of individuals, from healthy volunteers to those with the disease or condition being studied. Informed consent is a critical process in which participants are given comprehensive information about the trial, including its purpose, duration, required procedures, risks, potential benefits, and key contacts. Participants have the right to withdraw from a trial at any time.

Regulatory Aspects

In many countries, clinical trials must be approved by a regulatory body before they can begin. In the United States, the Food and Drug Administration (FDA) is the agency responsible for overseeing the conduct of clinical trials. The European Medicines Agency (EMA) performs a similar role in the European Union.